InspireMD has announced 12-month follow up data from PARADIGM-101 study of the CGuard Embolic Prevention System (EPS), which were presented at the Transcatheter Cardiovascular Therapeutics symposium (TCT 2016, 29 October–2 November, Washington, DC, USA).
Piotr Musialek, Jagiellonian University Department of Cardiac and Vascular Diseases, Krakow, Poland, reported 12-month follow up data from PARADIGM-101, an investigator-led clinical study evaluating the use of CGuard in 101 consecutive patients with carotid artery stenosis.
Key findings from the presentation included:
- Zero device-related adverse events at 12 months
- Device and procedure success were each 99.1%.
- Vessel narrowing was reduced from 83±9% to only 6.7±5% (p < 0.001) by independent core lab analysis
- Periprocedural death/major stroke/myocardial infarction was 0%.
- One periprocedural event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking scale and no clinical sequelae
- At 12 months the device showed a normal healing profile, and the patency of the external carotid artery was normal
“These data further reinforce the strong safety and efficacy profiles reported in previous trials of the CGuard EPS, and validate the system as an important option for endovascular management of patients with carotid artery disease,” said Musialek.
“Importantly, the very low incidence of peri- or post-procedural complications and stroke create a positive risk-benefit profile for CGuard EPS in patients with asymptomatic carotid artery disease. These patients are frequently denied intervention due to fear of the complications associated with conventional intervention, and are left with a substantial risk of stroke when treated only with medication. Our study found that CGuard EPS is applicable in up to 90% of all-comer patients with carotid stenosis. These data indicate that CGuard EPS may fundamentally alter the paradigm for managing patients with carotid artery disease, whether they have symptoms or not,” he added.
CGuard EPS is CE marked and not approved for sale in the US by the Food and Drug Administration at this time.